IT Executive-Pharmaceutical Industry (GMP & CSV)

Job Title: IT Executive / IT Officer – Pharmaceutical Industry (GMP & CSV)

Department: Information Technology (IT)

Industry: Pharmaceutical / Pharma Manufacturing

Job Type: Full-Time

Job Summary

We are looking for a skilled and responsible IT Executive / IT Officer to manage IT infrastructure, network connectivity, servers, hardware, software, ERP systems, data backups, and IT-related compliance activities in a pharmaceutical manufacturing environment. The candidate should have a good understanding of GMP, GLP, 21 CFR Part 11, Computer System Validation (CSV), and data integrity requirements.

Key Responsibilities1. IT Infrastructure & Technical Support

• Manage and maintain IT infrastructure, including servers, firewalls, desktop computers, laptops, printers, network switches, cabling, and internet connectivity.
• Maintain and troubleshoot network infrastructure, CCTV systems, EPABX/telephone systems, and biometric attendance systems.
• Provide daily technical support to users for hardware, software, ERP, and network-related issues.
• Maintain IT assets, software configurations, passwords, access controls, and system settings.
• Coordinate with vendors and service providers for troubleshooting, repairs, upgrades, and maintenance.
• Maintain EMS, BMS, SCADA software and hardware, and other computerized systems as applicable.
• ERP & Software Management
• Manage and provide user support for PharmaCloud ERP software and resolve day-to-day functional and technical queries.
• Maintain HR and biometric attendance software.
• Coordinate with respective departments and software vendors for system updates, configuration changes, and troubleshooting.
• Generate and maintain daily, weekly, and periodic IT and system-related reports as required.
• Ensure appropriate user access, password management, and configuration control for all IT systems.
• GMP, GLP & Regulatory Compliance
• Ensure compliance with applicable GMP and GLP requirements for IT systems and computerized equipment.
• Support compliance with 21 CFR Part 11 requirements, electronic records, electronic signatures, and audit trail management, as applicable.
• Assist in Computer System Validation (CSV), including reviewing and monitoring validation protocols and related documentation.
• Provide audit trail reports for QC and Production instruments, machines, and computerized systems.
• Assist in internal, external, regulatory, and customer audits, including audit preparation, documentation, and compliance activities.
• Coordinate with Quality Assurance (QA), Quality Control (QC), Production, and other departments to address computerized system compliance requirements.
• Follow applicable IT policies, SOPs, data integrity requirements, and change control procedures.
• Data Backup & System Maintenance
• Verify daily backups of Production, QC, and other departmental and user data.
• Monitor backup completion and coordinate corrective action in case of backup failures.
• Maintain and monitor servers, software applications, system configurations, and related IT infrastructure.
• Verify time synchronization of computerized systems, network devices, and applicable clocks.
• Ensure proper completion and maintenance of relevant logbooks and IT documentation.
• Coordinate with users and suppliers for software changes, breakdowns, upgrades, and configuration modifications.
• IT Administration & Planning
• Maintain daily records of IT issues, resolutions, preventive maintenance, and system activities.
• Monitor ongoing IT activities and plan for future infrastructure expansion based on organizational requirements.
• Ensure adherence to company policies, departmental procedures, and working hours as prescribed by the HR and Administration Department.
• Perform additional quality, GMP, GLP, and IT-related responsibilities assigned by the reporting manager.

Required Skills

• Strong knowledge of computer hardware, software, networking, servers, and IT troubleshooting.
• Experience in LAN/WAN, network switches, firewalls, CCTV, EPABX, printers, and internet connectivity.
• Knowledge of ERP systems, preferably PharmaCloud ERP.
• Understanding of GMP, GLP, data integrity, 21 CFR Part 11, and Computer System Validation (CSV).
• Knowledge of data backup, access control, audit trails, change control, and IT documentation.
• Good coordination, communication, problem-solving, and documentation skills.
• Ability to work effectively with QA, QC, Production, HR, Administration, and external vendors.

Education & Experience

• Qualification: Diploma/Bachelor’s degree in IT, Computer Science, Computer Engineering, or a related field.
• Experience: Experience in IT support and infrastructure management, preferably in the pharmaceutical industry.
• Candidates with pharmaceutical GMP/GLP compliance, ERP support, and CSV experience will be preferred.

Pay: ₹15,000.00 - ₹25,000.00 per month

Benefits

• Provident Fund

Work Location: In person